This study will assess the safety and efficacy of KRP203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Frankfurt am Main, Germany
Novartis Investigative Site
Tübingen, Germany
Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Time frame: 12 weeks
Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus
Time frame: 12 weeks
Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients
Time frame: 12 weeks
Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient
Time frame: 12 weeks
Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time frame: 12 weeks
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Novartis Investigative Site
Athens, GR, Greece
Novartis Investigative Site
Thessaloniki, GR, Greece
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Siena, SI, Italy